Trial record 1 of 1 for:    gog-9924
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Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01074411
First received: February 23, 2010
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

This phase I trial is studying the side effects and best dose of intraperitoneal bortezomib when given together with intraperitoneal carboplatin in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may help carboplatin work better by making tumor cells more sensitive to the drug. Infusing bortezomib and carboplatin directly into the abdomen may kill more tumor cells.


Condition Intervention Phase
Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: bortezomib
Drug: carboplatin
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Study of Intraperitoneal CTEP-Supplied Agent Bortezomib (PS-341, NSC 681239) and Carboplatin (NSC# 241240) in Patients With Persistent or Recurrent Ovarian Fallopian Tube, or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Dose-limiting toxicities during the first course of therapy [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Frequency and severity of toxicities as assessed by NCI CTCAE criteria [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective tumor response (complete and partial response) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetic measures of bortezomib [ Time Frame: 10 minutes prior to infusion; immediately following infusion; 15, 30 and 60 minutes after infusion; immediately following carboplatin; 90 minutes after infusion; and 2, 4, and 6 hours after infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2010
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (bortezomib, carboplatin)

Patients receive bortezomib IP and carboplatin IP on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Plasma and peritoneal fluid samples are collected at baseline and periodically during the first course of therapy for pharmacokinetic studies.

Drug: bortezomib
Given IP
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Drug: carboplatin
Given IP
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of intraperitoneal (IP) bortezomib (BTZ) when administered with IP carboplatin in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent or recurrent and who have failed primary therapy and at least one second-line therapy.

II. To examine the safety of administering BTZ in combination with carboplatin by the IP route.

SECONDARY OBJECTIVES:

I. To estimate objective tumor response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

II. To determine the pharmacokinetic profile of BTZ and carboplatin when administered intraperitoneally once every 21 days.

III. To characterize the frequency of carboplatin hypersensitivity reactions (HSR) when administered as an intraperitoneal infusion in the context of recurrent ovarian cancer.

OUTLINE: This is a multicenter, dose-escalation study of bortezomib.

Patients receive bortezomib intraperitoneal (IP) and carboplatin IP on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Plasma and peritoneal fluid samples are collected at baseline and periodically during the first course of therapy for pharmacokinetic studies.

After completion of study treatment, patients are followed every 3 months for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer, including one of the following epithelial cell types*:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
  • Persistent or recurrent disease (either "platinum-sensitive" or platinum-resistant")

    • Has failed primary therapy AND 1-2 second-line therapies

      • No more than 3 prior second-line therapies in the recurrent disease setting
  • Measurable or detectable disease

    • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension with the following:

      • Lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam, OR ≥ 20 mm by chest x-ray
      • Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI
    • Detectable disease defined as any of the following:

      • CA-125 baseline values of ≥ 2 times upper limit of normal
      • Ascites and/or pleural effusion attributed to tumor
      • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
  • No synchronous primary endometrial cancer or history of primary endometrial cancer unless the primary origin of the recurrent or persistent tumor is ovarian or peritoneal AND all of the following criteria are met:

    • Stage of endometrial cancer is ≤ IB
    • No more than superficial myometrial invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
  • No known brain metastases
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm^3 (not induced or supported by granulocyte colony-stimulating factors)
  • Platelet count ≥ 100,000/mm^3
  • Creatinine normal
  • Calculated creatinine clearance > 50 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • INR ≤ 1.5 times ULN (or 2-3 for patients on a stable dose of therapeutic warfarin)
  • PTT ≤ 1.5 times ULN

    • Heparin, low molecular weight heparin, or alternative anticoagulants allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer and localized breast cancer, including localized cancer of the breast, head and neck, or skin adequately treated for > 3 years with no evidence of disease recurrence
  • Neuropathy (sensory and motor) < grade 1
  • No myocardial infarction within the past 12 months
  • No new evidence of acute ischemia or conduction abnormalities by ECG
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection requiring parenteral antibiotics
    • Acute hepatitis
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No active infection requiring antibiotics except for uncomplicated urinary tract infection
  • No history of allergic reactions attributed to carboplatin or compounds of similar chemical or biologic composition to bortezomib, including boron or mannitol
  • No insulin-dependent diabetes
  • No other concurrent investigational agents
  • Must have had 1 prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound that included any of the following:

    • Non-cytotoxic therapy
    • Intraperitoneal therapy
    • Consolidation therapy
    • Extended therapy
  • At least 1 prior cytotoxic regimen for the management of recurrent of persistent disease
  • Recovered from the effects of recent surgery, radiotherapy, or chemotherapy
  • No prior bortezomib
  • No prior cancer treatment that would contraindicate study treatment
  • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Continuation of hormone replacement therapy allowed
  • At least 3 weeks since any other therapy directed at the malignant tumor, including biological and immunologic agents
  • No prior radiotherapy or chemotherapy for any abdominal or pelvic tumor other than ovarian cancer

    • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin that remains free of recurrence or metastatic disease allowed
    • More than 3 years since prior adjuvant chemotherapy for localized breast cancer that remains free of recurrence or metastatic disease allowed
  • Concurrent ovarian estrogen and/or progestin replacement therapy for control of menopausal symptoms allowed provided it is administered at the lowest effective dose(s)
  • No concurrent progestins for the management of anorexia
  • No concurrent prophylactic growth factors (filgrastim, sargramostim, or pegfilgrastim
  • No concurrent amifostine or other protective reagents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074411

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Investigators
Principal Investigator: Don Dizon NRG Oncology
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01074411     History of Changes
Other Study ID Numbers: NCI-2011-02014, NCI-2011-02014, CDR0000665312, GOG-9924, GOG-9924, U10CA180868, U10CA027469
Study First Received: February 23, 2010
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Brenner Tumor
Carcinoma
Carcinoma, Endometrioid
Cystadenocarcinoma
Cystadenocarcinoma, Mucinous
Cystadenocarcinoma, Serous
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Endometrial Neoplasms
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on October 23, 2014